Packaging Systems And Methods For Mounting A Tool On A Surgical Device Using The Same

ABSTRACT

Packaging systems and surgical kits for a tool that has a cutting bur and a shaft. A casing includes a distal section defining a cavity to receive the cutting bur of the tool. A proximal section is coupled to the distal section and receives the shaft of the tool. The proximal section is detachable from the distal section. At least a portion of the distal section comprises a colored indicator to provide a visual indication of a location of the cutting bur of the tool. Instructions are provided on the proximal section and the instructions illustrate one or more steps for installing the tool to a surgical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. Non-provisional patentapplication Ser. No. 16/890,339, filed on Jun. 2, 2020, which claimspriority to and all the benefits of U.S. Provisional Patent App. No.62/857,419, filed on Jun. 5, 2019, the entire contents of each of theaforementioned applications being hereby incorporated by reference.

BACKGROUND

A surgical device such as a robot often receives a tool or instrumentfor use during a surgical procedure. The tool may be a cuttingaccessory, such as a bur or drill, having a head with sharp featuresconfigured to resect tissue such as bone. Suboptimal packaging andhandling of the tool may result in surgical site infection, injury, andother undesirable consequences.

Surgical site infections (SSIs) are one of the most commonly identifiedtypes of healthcare associated infections. The SSIs relevant to thepresent disclosure result from contamination of the tool with infectiousmaterial during handling and mounting of the tool on the surgicaldevice. Known methods may include a user, such as an operating roomtechnician, removing the tool from packaging and placing it on a tableuntil it is necessary to mount the tool on the surgical device. The toolmay be placed in intermediate packaging such as a poly bag, after whichthe user removes the tool from the poly bag for mounting on the surgicaldevice. The known methods require the tool be physically handled by theuser after removal from the packaging or intermediate packaging. For anelongate tool having a shaft coupled to the head, the shaft is mountedon the surgical device and requires the user to handle the toolproximate the head and its sharp features. It is well documented thathand hygiene is not always correctly performed, and proper hand hygienemay not always remove all pathogenic organisms. The inadvertenttransference of pathogenic organisms from the user to the tool increasesthe risk of SSIs.

Known packaging also may not adequately prevent contact between thesharp features of the cutting accessory and the packaging duringhandling and removal of the tool. The user may, for example, pluck theshaft of the tool from the packaging. Should the head of the cuttingaccessory contact the packaging body during handling or removal, thesharp features may shave or otherwise remove small bits of thepackaging. The bits may be imperceptible and remain on the head of thecutting accessory after being mounted on the surgical device. The bitsmay be introduced to the patient during the surgical procedure andincrease the risk of SSIs from the body's response to the foreignmaterial.

Often with surgical devices comprising a robot, the tool is mounted tothe robot in advance of its use during the surgical procedure. In theinterim, the head of the tool and its sharp features remain exposed inan unprotected manner for some time up to the point of use. Theunprotected tool is associated with risk of contamination and/or injury,particularly as a surgical team moves about the operating room. Forexample, the operating room technician may inadvertently bump into thetool causing contamination of the tool, injury to the technician, and/ordamage to the surgical device.

Furthermore, providing suitable packaging for surgical tools may requireone or more components with intricate features that are costly tomanufacture. The complexity and costs of the manufacturing and assemblyprocesses may be further influenced by regulatory requirements andindustry standards.

The issues above are complicated further by situations in which the toolthat is mounted to the surgical device must be rotated by the technicianin order to be properly installed in the surgical device. For example,the tool and surgical device may have corresponding alignment parts.When the technician applies force to install the tool, the correspondingalignment features cause the tool to rotate and align to the surgicaldevice. If the tool is coupled to the packaging in a rotationally fixed(non-moveable) manner, then rotation of the tool during alignment willrequire rotation of the entire packaging. This creates ergonomic issuesfor the technician thereby making the installation process sub-optimal.Furthermore, in such situations, the technician may be inclined toremove the packaging, thereby destroying the purpose of the packaging byreintroducing potential contamination of the tool or injury to thetechnician.

Packaging systems and methods designed to overcome one or more of theaforementioned disadvantages are desired.

SUMMARY

This Summary introduces a selection of concepts in a simplified formthat are further described below in the Detailed Description. ThisSummary is not intended to limit the scope of the claimed subject matterand does not necessarily identify each and every key or essentialfeature of the claimed subject matter.

According to a first aspect, a packaging system is provided for a toolthat has a cutting bur and a shaft, the packaging system comprising: acasing comprising a distal section defining a cavity configured toreceive the cutting bur of the tool; and a proximal section coupled tothe distal section and configured to receive the shaft of the tool, andthe proximal section being detachable from the distal section; whereinat least a portion of the distal section comprises a colored indicatorto provide a visual indication of a location of the cutting bur of thetool; and wherein instructions are provided on the proximal section andthe instructions are configured to illustrate one or more steps forinstalling the tool to a surgical device.

According to a first aspect, a surgical kit is provided comprising: atool including a cutting bur and a shaft; and a packaging systemcomprising: a casing comprising a distal section defining a cavityconfigured to receive the cutting bur of the tool; and a proximalsection coupled to the distal section and configured to receive theshaft of the tool, and the proximal section being detachable from thedistal section; wherein at least a portion of the distal sectioncomprises a colored indicator to provide a visual indication of alocation of the cutting bur of the tool; and wherein instructions areprovided on the proximal section and the instructions are configured toillustrate one or more steps for installing the tool to a surgicaldevice.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present disclosure will be readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanying drawingswherein:

FIG. 1 is a perspective view of a packaging system in accordance with anexample embodiment of the present disclosure.

FIG. 2 is a perspective view of an elongate tool.

FIG. 3 is a perspective view of a packaging body in accordance with anexample embodiment of the present disclosure with an elongate tooldisposed within the packaging body in a first configuration.

FIG. 4 is a top plan view of the packaging body of FIG. 3.

FIG. 5 is a perspective view of the packaging body of FIG. 3 in a secondconfiguration with the elongate tool removed from the packaging body.

FIG. 6 is a perspective view of the packaging body of FIG. 3 with theelongate tool disposed within the packaging body in an installationconfiguration.

FIG. 7 is a perspective view of the packaging body of FIG. 3 with aproximal section detached from a distal section so as to expose aproximal portion of the elongate tool.

FIG. 8 is a packaging body in accordance with another example embodimentof the present disclosure with the elongate tool disposed within thepackaging body in the first configuration.

FIG. 9 is a perspective view of the packaging body of FIG. 8 in a secondconfiguration with the elongate tool removed from the packaging body.

FIG. 10 is a side elevation view of the packaging body of FIG. 8 withthe elongate tool disposed within the packaging body in the firstconfiguration.

FIG. 11 is a surgical device.

FIG. 12 shows a step of an example method of mounting the elongate toolon the surgical device.

FIG. 13 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 14 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 15 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 16 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 17 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 18 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 19 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 20 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 21 shows a step of coupling a casing of the packaging body to theelongate tool.

FIG. 22 shows another step of coupling the casing of the packaging bodyto the elongate tool.

FIG. 23 is a perspective view of a packaging system in accordance withanother example embodiment of the present disclosure with an elongatetool disposed within a packaging body.

FIG. 24 is a perspective view of the elongate tool.

FIG. 25 is a perspective view of a casing of the packaging body of FIG.23 in an opened or second configuration.

FIG. 26 is a perspective view of a packaging system in accordance withanother example embodiment of the present disclosure with an elongatetool disposed within the packaging body.

FIG. 27 is an exploded view of the packaging system of FIG. 26.

FIG. 28 is a perspective view of a casing of the packaging body of FIG.26

FIG. 29 is a top plan view of a packaging system in accordance withanother example embodiment of the present disclosure with instructionalmarkings disposed on a proximal section of the packaging body.

FIG. 30 shows a step of an example method of mounting the elongate toolof FIG. 24 on the surgical device with the packaging body of FIG. 23.

FIG. 31 shows another step of the example method of mounting theelongate tool on the surgical device.

FIG. 32 a step of an example method of mounting the elongate tool ofFIG. 24 on the surgical device with the packaging body of FIG. 26.

FIG. 33 shows another step of the example method of mounting theelongate tool on the surgical device.

DETAILED DESCRIPTION I. Packaging System

FIG. 1 shows a packaging system 20 according to one example embodiment.The packaging system 20 includes a segmented packaging body 22configured to removably receive an elongate tool 24. Secondary packaging26 may be provided and configured to receive the packaging body 22. Inthe embodiment illustrated in FIG. 1, the secondary packaging 26includes a sealed pouch having opposing layers coupled through, forexample, heat sealing, adhesive, and the like. The seal 29 may extendaround the packaging body 22 once disposed between the layers to providea hermetic seal. The layers of the secondary packaging 26 may be peeledapart to expose the packaging body 22 for functions to be disclosed.

The secondary packaging 26 may include a blister pack. A tray with acavity is formed within a suitable material, preferably thermoformedplastic. The cavity may be formed in a suitable geometry to accommodatethe packaging body 22. A film is removably attached about a periphery ofthe formed tray to provide a peel-open feature. The film may be porousto allow sterilization. One suitable film is Tyvek® manufactured byDuPont™ (Wilmington, Del.). In another example, the film may be applieddirectly to the packaging body 22. In such an example, the film providessupplemental security for the tool 24 within the packaging body 22.Other types of secondary packaging are contemplated, but it is to beunderstood the packaging systems described herein may include thepackaging body without secondary packaging.

The packaging system 20 provides safe, sterile and secure handling ofthe tool 24 during storage, transport, and mounting of the tool 24 on asurgical device 28 (see FIG. 11). FIG. 2 shows an example tool for usewith the packaging systems described herein. The tool 24 includes adistal end 30 and a proximal end 32 opposite the distal end 30. A lengthof the tool 24 is defined between the distal end 30 and the proximal end32. A tool axis 34 may be defined between the distal end 30 and theproximal end 32. A width of the tool 24 is less than the length suchthat the tool 24 may be defined as elongate. The tool 24 of FIG. 2 iscircular in cross section, but it is to be understood that othersuitable shapes are contemplated, including triangles, squares, andhigher order polygons. The tool could be curved or a non-linearelongated device, or it could be a movable multi-piece assembly. Othertypes of surgical tools are contemplated.

The proximal end 32 is configured to be coupled to the surgical device28. The surgical device 28 may be any apparatus configured to receivethe tool 24. The tool 24 may be the instrument that directly interfaceswith the patient, whereas the surgical device 28 may provide actuation,control, power, and the like to the tool 24. The surgical device 28 ofFIG. 11 is a surgical robot R having an end effector EE configured toreceive the tool 24. In certain embodiments, the tool 24 is a resectioninstrument such as a surgical bur or drill. FIG. 2 shows the surgicalbur with the distal end 30 comprising a head 36 with the head 36 rigidlycoupled to a shaft 38 extending to the distal end 32. Example surgicalburs include the CORE™ Burs manufactured by Stryker® Corporation(Kalamazoo, Mich.).

Other examples of the tool 24 and the surgical device 28 configured toreceive the tool 24 are contemplated. For example, possible combinationsof the tool 24 and the surgical device 28 may include: a router, acurved bur, or a sleeve connector for a bur configured to be received bya handheld rotary instrument; electrodes configured to be received by asmoke evacuation pencil; a saw or a blade configured to be received by asaw driver; a scalpel configured to be received by a scalpel handle; anultrasonic tip configured to be received by a sonopet; and an endoscopicshaver or cutter configured to be received by an endo-handpiece. It isto be understood that other surgical devices for receiving tools arecontemplated.

A cutting accessory sleeve (not shown) or collet may be provided anddisposed about the shaft 38. The packaging body 22 may be suitablyshaped to accommodate the tool 24 with or without the cutting accessorysleeve coupled to the shaft 38. Receiving the cutting accessory sleevewithin the packaging body 22 may facilitate improved mounting of thetool 24 on the surgical device 28 in manners to be described.

Referring to FIGS. 3-5, the segmented packaging body 22 of the presentembodiment of the packaging system 20 is shown. The packaging body 22includes a first distal section 42 and a second distal section 44. Thefirst distal section 42 includes a first boundary and a second boundary.In some embodiments, the boundaries include a distal boundary 46 and aproximal boundary 48. The second distal section 44 is coupled to thefirst distal section 42 at the distal boundary 46. The packaging body 22further includes a proximal section 50 coupled to the first distalsection 42 at the proximal boundary 48. The packaging body may beincluded in part or entirely of polyethylene terephthalateglycol-modified (PETG). Other suitable materials may include, withoutlimitation, polymers such as polyethylene terephthalate (PET),high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-densitypolyethylene (LDPE), polypropylene (PP), and polystyrene (PS), epoxy andother resins, and malleable metals such as aluminum. The packaging body22 is preferably formed by thermoforming, but injection molding, vacuummolding, blow molding, and other manufacturing processes are alsocontemplated.

The first and second distal sections 42, 44 are configured to receivethe distal end 30 of the tool 24. FIGS. 3 and 4 show the first andsecond distal sections 42, 44 receiving the distal end 30 and a portionof the shaft 38 of the tool 24. The first and second distal sections 42,44 may be pivotally coupled to provide a casing 52 to the distal end 30of the tool 24.

The casing 52 may be provided by a cavity 54, 56 disposed in each of thefirst and second distal sections 42, 44. With reference to FIGS. 3 and5, the first distal section 42 includes a primary surface 58 extendingbetween the distal boundary 46 and the proximal boundary 48. The cavity54 may be disposed within the primary surface 58 and positionedintermediate the distal boundary 46 and the proximal boundary 48. Thesecond distal section 44 includes a primary surface 60 with the cavity56 disposed within the primary surface 60. The primary surfaces 58, 60may be considered as substantially flat portions of first and seconddistal sections 42, 44 to which many of the features described hereinare formed or otherwise coupled. The cavities 54, 56 of each of thefirst and second distal sections 42, 44 may be in substantial alignmentso as to receive the distal end 30 of the tool 24 in a firstconfiguration to be described. In other embodiments, only one of firstand second distal sections 42, 44 may include a cavity suitablydimensioned to receive the distal end 30 of the tool 24 with the otherone of first and second distal sections 42, 44 being substantially flat.In certain embodiments, the proximal section 50 may include a flatsurface devoid of the cavity 86. In such an example, the flat surfacemay extend adjacent to the shaft 38 of the tool 24.

The casing 52 may be provided by articulating one of the first andsecond distal sections 42, 44 relative to the other to the firstconfiguration shown in FIGS. 3 and 4. The second distal section 44 maybe pivotally coupled to the first distal section 42 at the distalboundary 46. In certain embodiments, the second distal section 44 ispivotally coupled to the first distal section 42 about an axis 66perpendicular to the tool axis 34 of the tool 24. In certainembodiments, the tool 24 may be curved, such as a curved portionextending distally from a straight portion. In such an embodiment, thecasing 52 may be generally arcuate in shape. Alternatively, thepackaging may be oriented similar to that shown in FIG. 4, but otherwiseconfigured to accommodate the curved tool.

In one example, the packaging body 22 includes a living hinge 62 at thedistal boundary 46. The living hinge 62 may be described as a thin,flexible connection or web coupling first and second distal sections 42,44. The living hinge 62 may be a consequence, at least in part, ofperforations 64 at the distal boundary 46. In some cases, the firstdistal section 42 may be configured to be detachable from the seconddistal section 44 at the perforations 64. Other suitable ways ofeffectuating relative movement between the first and second distalsections 42, 44 are contemplated. For example, a flexible material maycouple the first and second distal sections 42, 44 and/or may couple thefirst distal section 42 and the proximal section 50. In such anembodiment, the first and second distal sections 42, 44 and the proximalsection 50 are discrete structures coupled by the material adapted tobend so as to enable the relative pivoting at the distal boundary 46and/or the proximal boundary 48. In one example, the flexible materialincludes an adhesive adapted to join an adjacent two of the sections 42,44, 50. A portion of the flexible material is adhered to each of theadjacent two of the sections 42, 44, 50 with or without a small gapdisposed between the adjacent two of the sections 42, 44, 50. Ifdesired, the adjacent two of the sections 42, 44, 50 may be separated byproviding sufficient force to overcome the adhesive force.

The second distal section 44, for example, may be pivoted relative tothe first distal section 42 to provide the casing 52. In other words, atleast one of the first and second distal sections 42, 44 is configuredto move between the first configuration and a second configuration. Inthe second configuration to be described in greater detail, the firstand second distal sections 42, 44 are positioned in a non-abuttingrelationship. In the first configuration, the first and second distalsections 42, 44 are positioned in an abutting relationship such that thedistal end 30 of the tool 24 is encased between the first and seconddistal sections 42, 44. In the example embodiment shown in FIGS. 4 and5, the second distal section 44 may be moved or folded over onto thefirst distal section 42 such that the primary surfaces 58, 60 are in adirect abutting relationship. The movement is guided by the living hinge62 oriented on the axis 66 such that the first and second distalsections 42, 44 are generally aligned atop one another in the firstconfiguration. The direct abutting relationship of the primary surfaces58, 60 provides the casing 52 to the distal end 30 of the tool 24. Inthe first configuration, the primary surfaces of the first and seconddistal sections 42, 44 are substantially parallel.

In certain embodiments, including those illustrated throughout thepresent disclosure, the distal boundary 46 is opposite the proximalboundary 48 such that in the second configuration, the first and seconddistal sections 42, 44 and the proximal section 50 are generally alignedor positioned in-line, as illustrated in FIG. 5. In other words, in thesecond configuration with the primary surfaces 58, 60 of the first andsecond distal sections 42, 44 positioned in a non-abutting relationship,the first distal section 42 is positioned adjacent the second distalsection 44 opposite the proximal section 50. Certain modifications ofthe packaging body 22 are contemplated. For example, one of the lateraledges 67 (see FIG. 4) may include the living hinge 62 about which one ofthe first and second distal sections 42, 44 is configured to movebetween the first configuration and the second configuration. In such anexample, the first and second distal sections 42, 44 are pivotallycoupled at a side boundary and not at the distal boundary 46. Thefunction of the casing 52 is substantially as described with therelative pivoting about one of the lateral edges 67 resulting in thesections 42, 44, 50 assuming an L-shaped configuration.

The packaging body 22 further includes couplers 68 removably couplingthe first and second distal sections 42, 44. The couplers 68 areconfigured to maintain the first and second distal sections 42, 44 inthe first configuration absent an input from a user to be described. Thecouplers 68 may operate by interference or friction fit, but other modesof securing the first and second distal sections 42, 44 arecontemplated, such as adhesive. In certain embodiments, the couplers 68include a protrusion 70 removably coupled to a recess 72 by interferencefit in the first configuration. More specifically, the recess 72 may beprovided within one of the first and second distal sections 42, 44, andthe protrusion 70 provided on the other one of the first and seconddistal sections 42, 44. In the example embodiment shown in FIGS. 3-5,two recesses 72 are provided within the first distal section 42, and twoprotrusions 70 provided on the second distal section 44. The protrusions70 and recesses 72 are positioned on opposing sides of the cavities 54,56 of the first and second distal sections 42, 44, respectively. Theprotrusion 70 and the recess 72 may extend from the primary surfaces 58,60 of the first and second distal sections 42, 44. The interference fitbetween the protrusion 70 and the recess 72 maintains the casing 52 suchthat the first and second distal sections 42, 44 encase the distal end30 of the tool 24. Additionally or alternatively, additional structuresmay be formed within the cavities 54, 56 to create an interference fitbetween the first and second distal sections 42, 44 to maintain thecasing 52 in the first configuration. In other example embodiments, oneof the first and second distal sections 42, 44 may include edges with a“folded” or “crimped” shape so as to create the interference fit (orsnap-fit) with edges of the other one of the first and second distalsections 42, 44. For example, the lateral edges 67 of the second distalsection 44 may be formed such that the lateral edges 67 deflect whenmoving the casing 52 of the packaging body 22 between the first andsecond configurations. The casing 52 provides, among other advantages tobe described, secure handling of the distal end 30 of the tool 24.

The second configuration provides positioning the first and seconddistal sections 42, 44 in the non-abutting relationship, therebyexposing a portion of the distal end 30 of the tool 24 disposed withinthe first distal section 42. FIG. 5 shows the second configuration (withthe tool 24 removed). Positioning the packaging body 22 in the secondconfiguration typically occurs after the tool 24 is mounted on thesurgical device 28 in a manner to be described. Moving the packagingbody 22 from the first configuration to the second configurationincludes pivoting one of the first and second distal sections 42, 44relative to the other. In one example, one of the first and seconddistal sections 42, 44 is pivoted about the distal boundary 46comprising the living hinge 62 oriented on the axis 66 transverse to thetool axis 34. The desired movement may be further facilitated by cutouts74 disposed at opposing ends of the distal boundary 46. The cutouts 74include material removed or absent from one or more of the first andsecond distal sections 42, 44 at the opposing ends of the distalboundary 46, as shown in FIGS. 3-5. The cutouts 74 may include materialremoved or absent from one or more of the first distal section 42 andthe second distal section 44 at a singular one of the opposing ends ofthe distal boundary 46. The cutouts 74 of the illustrative embodimentare generally triangular when viewed in plan, but other suitable shapesare contemplated. The cutouts 74 may localize stresses at the opposingends of the distal boundary 46 to facilitate relative pivoting of firstand second distal sections 42, 44 at the distal boundary 46.

The relative pivoting is typically imparted by the user holding thepackaging body 22. In one example, the user may hold the proximalsection 50 and/or the first distal section 42 in one hand and grasp thesecond distal section 44 with the other hand in order to overcome theinterference fit of the couplers 68. The user may use fingers to pinchor grasp the second distal section 44 while holding the first distalsection 42. The packaging body 22 may further include a finger grip 76configured to be grasped by the fingers of the user. The second distalsection 44 includes the finger grip 76 positioned and/or extendingoutwardly from the first distal section 42. FIGS. 3-5 show two fingergrips 76 positioned on opposite sides of the cavity 56. In certainembodiments, the finger grip 76 may include a portion of the primarysurface 60 of the second distal section 44 extending outwardly from thefirst distal section 42. The portion of the primary surface 60 may bepositioned adjacent and/or proximate to cutouts 80 associated with theproximal boundary 48 for functions to be described. The finger grip 76in combination with the cutouts 80 provides a suitable surface tofacilitate disengagement of the interference fit of the couplers 68. Incertain embodiments, the finger grip 76 is the portion of the primarysurface 60 of the second distal section 44 to be grasped by the user toapply a force to disengage the protrusion 70 from the recess 72, therebyinitiating the relative pivoting of the first and second distal sections42, 44. Additionally or alternatively, the finger grip 76 may include atexturized feature 78 configured to be grasped between the fingers ofthe user. The texturized feature 78 further provides a gap between thefirst and second distal sections 42, 44 with the gap adapted to beengaged by one of the fingers of the user. In certain embodiments,material of durable strength, such as a string, may be provided andrigidly coupled to one of the first and second distal sections 42, 44.The material is adapted to be grasped by the user to facilitate movingthe casing 52 from the first configuration to the second configuration.In another example embodiment, a portion of the second distal section 44may include a tab of elevated material to be pinched between the fingersof the user to facilitate moving the casing 52 from the firstconfiguration to the second configuration.

The casing 52 may include features configured to prevent contact of thehead 36 of the tool 24 with the first and second distal sections 42, 44when the tool 24 is secured within the packaging body 22. Each of thefirst and second distal sections 42, 44 may include a boss 82 configuredto support the tool 24 proximate the distal end 30. Referring to FIG. 5,the boss 82 is disposed within the cavities 54, 56 of each of the firstand second distal sections 42, 44. The boss 82 may extend from a basesurface partially defining the cavity. The boss 82 may include a slot 84flanked by ridges with the slot 84 configured to receive the shaft 38 ofthe tool 24 proximal the head 36. The ridges are suitably sized suchthat when the couplers 68 are coupled in the first configuration, theshaft 38 of the tool 24 proximal the head 36 is securely encircledwithin the slots 84. The casing 52 may be considered substantiallycontoured to the distal end 30 of the tool 24. The head 36 of the tool24 is distal the boss 82, as shown in FIG. 4, and suspended with thecasing 52. In other words, the head 36 of the tool 24 is spaced at adistance from surfaces of the packaging body 22 to prevent contaminationof the tool 24. In one example, eight millimeters of clearance isprovided about the head 36 of the tool 24. In other examples, four, sixor ten or more millimeters of clearance may be provided. During mountingor installation of the tool 24 with the surgical device 28 as to bedescribed, the user may grasp the casing 52 without risk of touching thetool 24 and without contamination of the tool 24 from the packaging body22.

The packaging body 22 includes the proximal section 50 coupled to thefirst distal section 42 at the proximal boundary 48. The proximalsection 50 may further include a primary surface 88 coupled to theprimary surface 58 of the first distal section 42 at the proximalboundary 88. The primary surface 88 may be considered as substantiallyflat portions of proximal section 50 to which many of the featuresdescribed herein may be formed or otherwise coupled. The proximalsection 50 is configured to receive the proximal end 32 of the tool 24.Referring to FIGS. 3 and 4, the proximal section 50 receives a proximalportion of the shaft 38 of the tool 24 comprising the proximal end 32.The proximal section 50 includes a cavity 86 configured to receive theproximal portion of the tool 24. In certain embodiments, the cavity 86is disposed within the primary surface 88 and positioned intermediatethe proximal boundary 48 and a proximal edge 89 of the packaging body22. FIGS. 3-5 show the cavity 86 is an elongate cavity and suitablysized to receive the tool 24.

The tool 24 may be secured within the cavity 86 with one or more shaftcouplers 90. The shaft couplers 90 may include a protrusion with acounterposing recess. The protrusion may extend into the cavity 86 withthe counterposing recess extending outwardly from the cavity 86 oppositethe protrusion. The arrangement of the shaft coupler 90 provides aninterference fit to the shaft 38 of the tool 24. Based on the materialcomposition and thickness of the packaging body 22, a small amount ofelastic deformation of the shaft coupler 90 occurs as the tool 24 isurged within the cavity 86 of the proximal section 50. Once receivedwithin the cavity 86 the protrusion of the shaft coupler 90 positionedsuperior the tool 24 returns to a natural state and provides theinterference fit for the shaft 38 of the tool 24. FIGS. 3-5 show threeshaft couplers 90 spaced axially along the cavity 86 of the proximalsection 50, but one, two, four or more shaft couplers are contemplated.Each of the three shaft couplers 90 is arranged in an opposite mannerfrom an adjacent shaft coupler 90. In other words, the protrusion andthe counterposing recess of one shaft coupler 90 are “flipped” relativeto the adjacent shaft coupler 90. The resulting arrangement provides theinterference fit on radially opposite positions on the shaft 38 forimproved retention of the tool 24 within the proximal section 50.

The cavities 54, 56, 86 of the first and second distal sections 42, 44and the proximal section 50 are configured to receive a portion of thetool 24. The cavity 54 of the first distal section 42 and the cavity 86of the proximal section 50 may be substantially collinear. Inembodiments where the shaft 38 of the tool 24 is cylindrical and rigid,the cavities 54, 86 receiving a portion of the shaft 38 aresubstantially collinear or aligned to receiving the tool 24 within thepackaging body 22. FIGS. 3-5 show the cavity 54 of the first distalsection 42 and the cavity 86 of the proximal section 50 being continuoussuch that each of the cavities 54, 86 extend to the proximal boundary 48and form a singular channel between the first distal section 42 and theproximal section 50.

The proximal section 50 may be pivotally coupled to the first distalsection 42 at the proximal boundary 48. FIGS. 3-5 show the primarysurface 58 of the first distal section 42 pivotally coupled to theprimary surface 88 of the proximal section 50 at the proximal boundary48. The packaging body 22 may further comprising a living hinge 92 atthe proximal boundary 48 configured to facilitate pivoting the proximalsection 50 relative to the first distal section 42. The living hinge 92may be described as a thin, flexible connection or web coupling firstdistal section 42 and the proximal section 50, and more particularly theprimary surfaces 58, 88. The living hinge 92 may be a consequence, atleast in part, of a perforation 94 at the proximal boundary 48 forfunctions to be described.

The proximal section 50 is configured to move between a packagingconfiguration and an installation configuration. The packagingconfiguration, as shown in FIGS. 3 and 4, includes the proximal end 32of the tool 24 disposed within the cavity 86 of the proximal section 50.In the packaging configuration, the primary surfaces 58, 88 of the firstdistal section 42 and the proximal section 50 may be substantiallycoplanar. The packaging body 24 may be provided in the packagingconfiguration prior to installing or mounting the tool 24 on thesurgical device 28 in a manner to be described. Referring to FIG. 6, theinstallation configuration includes pivoting the proximal section 50relative to the first distal section 42, thereby exposing the proximalend 32 of the tool 24 outside the cavity 86 of the proximal section 50.Moving from the packaging configuration to the installationconfiguration may include pivoting the primary surface 88 of theproximal section 50 relative to the primary surface 58 of the firstdistal section 42 to expose the proximal end 32 of the tool 24 outsidethe cavity 86.

The living hinge 92 and the cutouts 80 facilitate the relative pivotingbetween the first distal section 42 and the proximal section 50 at theproximal boundary 48. The living hinge 92 may be oriented on an axis 96perpendicular to the tool axis 34 of the tool 24, as shown in FIG. 4,such that the proximal section 50 is pivotally coupled to the firstdistal section 42 about the axis 96 perpendicular to the tool axis 34 ofthe tool 24. The axis 96 of the living hinge 92 at the proximal boundary48 may be oriented parallel to the axis 66 of the living hinge 92 at thedistal boundary 46. In other embodiments when the tool 24 is curved, theaxis 96 may or may not be perpendicular to the tool axis 34 of the tool24. For example, the axis 96 may be oriented at any suitable anglerelative to the tool axis 34 to accommodate one or more curved portionsof the tool 24.

The packaging body 22 of the illustrated embodiments of the presentdisclosure, with the tool 24 disposed within the cavities 54, 56extending along a midline of the width, results in a generally symmetricconstruction of the packaging body 22. It is to be understood that thepackaging body 22 need not be symmetric in construction. For example,the illustrated embodiments show the living hinges 62, 92, and theperforations 64, 94 extending across an entirety of a width of thepackaging body 22 (e.g., between the cutouts 74, 80). In certainembodiments, the living hinges 62, 92, and/or the perforations 64, 94may extend across the packaging body 22 for only a portion of the width.In one example, the living hinges 62, 92, and/or the perforations 64, 94may be positioned entirely to one side of the tool axis 34 of the tool24. In other words, the living hinges 62, 92, and/or the perforations64, 94 extend from the cutouts 74, 80 to less than halfway across thewidth of the packaging body 22 (i.e., the midline of the otherwisesymmetric packaging body). Additionally or alternatively, one or moretabs (not shown) may be provided and coupled to or integral with one ofthe first and second distal sections 42, 44, and/or the proximal section50. The tab is positioned adjacent the perforation(s) 64, 94 and extendoutwardly from the packaging body 22. The tab is adapted to be graspedby a user to effectuate a tearing motion at the perforation(s) 64, 94with the user supporting the packaging body 22 opposite the perforation64, 94 to be engaged. The tab may be positioned on one or both sides ofthe packaging body 22. Furthermore, there may be only one perforation64, 94 provided to localize the tearing force provided by the user.

The cutouts 80 may be disposed at opposing ends of the proximal boundary48. The cutouts 80 include material removed or absent from one or moreof the first distal section 42 and the proximal section 50 at theopposing ends of the proximal boundary 48, as shown in FIGS. 3-5. Thecutouts 80 may include material removed or absent from one or more ofthe first distal section 42 and the proximal section 50 at a singularone of the opposing ends of the proximal boundary 48. The cutouts 80 ofthe illustrative embodiment are generally triangular when viewed inplan, but other suitable shapes are contemplated. The cutouts 80 maylocalize stresses at the opposing ends of the proximal boundary 48 tofacilitate relative pivoting of first distal section 42 and the proximalsection 50 at the proximal boundary 48. The relative pivoting istypically imparted by the user holding the packaging body 22. In oneexample, the user may hold the casing 52 in one hand and grasp theproximal section 50 with the other hand in order to pivot the proximalsection 50 relative to the casing 52.

The first distal section 42 may be detachably coupled to the proximalsection 50 at the proximal boundary 48. The packaging body 22 includesthe perforation 94 at the proximal boundary 48 configured to facilitatedetachment of the first distal section 42 from the proximal section 50,or vice versa. FIG. 7 shows the packaging body 22 subsequent todetachment of the proximal section 50 from the first distal section 42.The proximal section 50 may be detached from the first distal section 42either prior to or after mounting or installing the tool 24 on thesurgical device 28 in a manner to be described. The distal end 30 of thetool 24, including the head 36, may remain safely packaged in the casing52 subsequent to detachment of the proximal section 50 from the firstdistal section 42.

To detach the proximal section 50 from the first distal section 42, theuser may provide a force, through bending, pulling, rotating, orcombination thereof, sufficient to tear along the perforations 94. Theuser may support the casing 52 with the opposing hand, or the tool 24may be mounted on the surgical device 28 such that no user support maybe necessary. Care should be taken to ensure that the force provided todetach the proximal section 50 from the first distal section 42 does notprematurely decouple the couplers 68 of the casing 52, unless intendedby the user.

FIGS. 8-10 show a segmented packaging body 122 in accordance withanother example embodiment of the packaging system 20. Like componentsof the packaging body 22 of the previously described embodiment areidentified with a reference numeral increased by one hundred (100).Disclosure for the present embodiment of the packaging body 122abbreviated from the previously described embodiment is not to beconstrued as limiting unless specifically indicated.

The packaging body 122 is configured to removably receive the elongatetool 24 configured to be mounted on the surgical device 28. Secondarypackaging 26, such as the sealed pouch, the blister pack, or the like,may be provided and configured to receive the packaging body 122. Thepackaging body 122 includes the first distal section 142 and the seconddistal section 144. The first distal section 142 includes the distalboundary 146 and the proximal boundary 148. The second distal section144 is coupled to the first distal section 142 at the distal boundary146. The packaging body 122 further includes the proximal section 150coupled to the first distal section 142 at the proximal boundary 148.

The packaging body 122 may further include a transition section 143coupled to and positioned intermediate the first and second distalsections 142, 144. Based on the structure of the casing 152 of thepresent embodiment to be described, the transition section 143 providesspacing between the primary surfaces 158, 160 of the first and seconddistal sections 142, 144 such that, in the first configuration, thefirst and second distal sections 142, 144 are in the desired abuttingrelationship. The transition section 143 may define the distal boundary146.

The transition section 143 may include two or more living hinges 162separated by a surface. FIG. 8 shows the transition section 143 with twoliving hinges 162 such that, in the first configuration, the transitionsection 143 and first and second distal sections 142, 144 assume asubstantially U-shaped configuration. The living hinges 162 may bedescribed as a thin, flexible connection or web pivotally coupling eachof the first and second distal sections 142, 144 with the transitionsection 143. Perforations 164 may be associated with each of the livinghinges 162 such that the first distal section 142, the transitionsection 143, and/or the second distal section 144 are selectivelydetachable from one another.

The first and second distal sections 142, 144 are configured to receivethe distal end 30 of the tool 24. FIG. 8 shows the first and seconddistal sections 142, 144 receiving the distal end 130 and a portion ofthe shaft 38 of the tool 24. The first and second distal sections 142,144 may be pivotally coupled to provide the casing 152 to the distal end30 of the tool 24.

The casing 52 may be provided by the cavity 154, 156 disposed in each ofthe first and second distal sections 142, 144. With reference to FIG. 9,the first distal section 142 includes the primary surface 158 extendingbetween the distal boundary 146 and the proximal boundary 148. Thesecond distal section 144 includes the primary surface 160. The primarysurfaces 158, 160 may be considered as substantially flat portions offirst and second distal sections 142, 144. Each of the first and seconddistal sections 142, 144 may include the boss 182 configured to supportthe tool 24 proximate the distal end 30. In the packaging body 122 ofthe present embodiment, the bosses 122 extend from the primary surfaces158, 160 of the first and second distal sections 142, 144. The boss 182include the cavities 154, 156 configured to receive the shaft 38 of thetool 24 proximal the head 36. The cavity 154, 156 may be substantiallycontoured to a distal region of the tool 24 such that, when the couplers168 are coupled in the first configuration, the shaft 38 of the tool 24proximal the head 36 is securely encased within the casing 152.

The cavities 154, 156 of each of the first and second distal sections142, 144 may be in substantial alignment so as to receive the distal end30 of the tool 24 in a first configuration. The casing 152 may beprovided by articulating one of the first and second distal sections142, 144 relative to the other between the first configuration shown inFIG. 8, and the second configuration shown in FIG. 9. The second distalsection 144 may be pivotally coupled to the first distal section 142 atthe distal boundary 146 comprising the living hinges 162 orientedperpendicular to the tool axis 34 of the tool 24. In the presentembodiment, the boss 182 of each of the first and second distal sections142, 144 are provided in a direct abutting relationship in the firstconfiguration. With reference to FIG. 10, because the boss 182 of eachof the first and second distal sections 142, 144 extend from the primarysurfaces 158, 160 (with no cavity of the previously describedembodiment), spacing is required between the primary surfaces 158, 160to directly abut the bosses 182 in a flat-on-flat manner. The transitionregion 143 is suitably sized to provide the spacing required to achievethe direct abutting relationship shown in FIGS. 8 and 10. The primarysurfaces 158, 160 of the first and second distal sections 142, 144 maybe substantially parallel in the first configuration. The first andsecond distal sections 142, 144 are positioned in a non-abuttingrelationship in the second configuration as shown in FIG. 9 (with thetool 24 removed).

The packaging body 122 further includes the couplers 168 removablycoupling the first and second distal sections 142, 144. The couplers 168are configured to maintain the first and second distal sections 142, 144in the first configuration absent the input from the user. In certainembodiments, the couplers 168 include the protrusion 170 removablycoupled to the recess 172 by interference fit in the firstconfiguration. The recess 172 may be provided within the boss 182 of oneof the first and second distal sections 142, 144, and the protrusion 170provided within the boss 182 on the other one of the first and seconddistal sections 142, 144. In the example embodiment shown in FIGS. 8 and9, two recesses 172 and two protrusions 170 are provided. Theprotrusions 170 and recesses 172 are positioned on opposing sides of thecavities 154, 156 of the boss 182 of each of the first and second distalsections 142, 144. The interference fit between the protrusion 170 andthe recess 172 maintains the casing 152 such that the first and seconddistal sections 142, 144 encase the distal end 30 of the tool 24.

Moving the packaging body 122 from the first configuration to the secondconfiguration includes pivoting one of the first and second distalsections 142, 144 about the distal boundary 146 comprising the livinghinges 162 oriented transverse to the tool axis 34. The desired movementmay be further facilitated by the cutouts 174 comprising materialremoved or absent from one or more of the first and second distalsections 142, 144 at the opposing ends of the living hinges 162, asshown in FIGS. 8 and 9. In the second configuration, the cutouts 174 maybe trapezoidal when viewed in plan, but other suitable shapes arecontemplated. The cutouts 174 may localize stresses in a suitable mannerto facilitate relative pivoting of first and second distal sections 142,144 relative to the transition section 143 and one another.

The relative pivoting is typically imparted by the user holding thepackaging body 122. In one example, the user may hold the proximalsection 150 and/or the first distal section 142 in one hand and graspthe second distal section 144 with the other hand in order to overcomethe interference fit of the couplers 168. The user may use fingers topinch or grasp the second distal section 144 while holding of the firstdistal section 142. The spacing between the primary surfaces 158, 160may provide clearance for the user to pinch or grasp the primary surface160 of the second distal section 144. The packaging body 22 may furtherinclude the finger grip 176 comprising a portion of the primary surface160 of the second distal section 144 extending outwardly from the firstdistal section 142. The finger grip 176 may be positioned adjacentand/or proximate to the cutouts 180 associated with the proximalboundary 148.

The packaging body 122 includes the proximal section 150 coupled to thefirst distal section 142 at the proximal boundary 148. The proximalsection 150 may further include the primary surface 188 coupled to theprimary surface 158 of the first distal section 142 at the proximalboundary 148. The proximal section 150 is configured to receive aproximal portion of the shaft 38 of the tool 24 comprising the proximalend 32.

The proximal section 150 includes the cavity 186 configured to receivethe proximal portion of the tool 24. The cavity 186 may be providedwithin a proximal shelf 187. The proximal shelf 187 extends from theprimary surface 188 of the proximal section 150 and defines the cavity186. The proximal shelf 187 defining the cavity 186 is suitably sizedsuch that the cavity 186 of the proximal section 150 and the cavity 154of the first distal section 142 are aligned (e.g., substantiallycollinear). FIGS. 9 shows the cavity 186 is elongate and suitably sizedto receive the tool 24. The tool 24 may be secured within the cavity 186with the one or more shaft couplers 190 which include, for example, theprotrusions with the counterposing recesses to provide the interferencefit to the shaft 38 of the tool 24. The interference fit may be providedby a small amount of elastic deformation of the shaft coupler 190 thatoccurs as the tool 24 is urged within the cavity 186 of the proximalsection 150.

The cavity 154 of the first distal section 142 and the cavity 186 of theproximal section 150 may be separated by flat portions of the firstdistal section 142 and the proximal section 150. Referring to FIGS.8-10, the flat portion of the first distal section 142 may be defined asthe primary surface 158 intermediate the boss 182 and the proximalboundary 148 (see FP of FIG. 10). The flat portion of the proximalsection 152 may be defined as the primary surface 188 intermediate theproximal shelf 187 and the proximal boundary 148. The flat portionsprovide for, among other things, the proximal boundary 148 being linear.Consequently, the living hinge 192 and the perforations 194 at theproximal boundary 148 are linear. The living hinge 192 being linear mayfacilitate easier relative pivoting between the first distal section 142and the proximal section 150 with greater magnitudes of articulation.The perforation 194 being linear may facilitate easier detachment of theproximal section 150 from the first distal section 142 relative to morecomplex geometries.

The proximal section 150 is configured to move between the packagingconfiguration and the installation configuration. The packagingconfiguration, as shown in FIG. 8, includes the proximal end 32 of thetool 24 disposed within the cavity 186 of the proximal section 150. Inthe packaging configuration, the primary surfaces 158, 188 of the firstdistal section 142 and the proximal section 150 may be substantiallycoplanar. The flat portions may result in a portion of the shaft 38 ofthe tool 24 being exposed in the packaging configuration, as shown inFIG. 10. FIG. 8 also shows the first and second distal sections 142, 144in the first configuration; e.g., the boss 182 of the first and seconddistal sections 142, 144 are positioned in an abutting relationship. Inthe first configuration, the primary surfaces 158, 160 of the first andsecond distal sections 142, 144 may be substantially parallel.

The installation configuration includes pivoting the proximal section150 relative to the first distal section 142, thereby exposing theproximal end 32 of the tool 24 outside the cavity 186 of the proximalsection 150. The proximal section 150 may be configured to be moved fromthe packaging configuration to the installation configuration while thefirst and second distal sections 142, 144 are in the firstconfiguration. The living hinge 192 and the cutouts 180 facilitate therelative pivoting between the first distal section 142 and the proximalsection 150 at the proximal boundary 148. The living hinge 192 may beoriented on the axis 196 (see FIG. 8) perpendicular to the tool axis 34of the tool 24, and parallel to the living hinges 162 at the distalboundary 146. The cutouts 180 may include material removed or absentfrom one or more of the first distal section 142 and the proximalsection 150 at the opposing ends of the proximal boundary 148. The tool24 may be mounted on the surgical device 28 while the packaging body 122is in the installation configuration as to be described.

The first distal section 142 may be detachably coupled to the proximalsection 150 at the proximal boundary 148. The packaging body 122includes the perforations 194 at the proximal boundary 148 configured tofacilitate detachment of the first distal section 142 from the proximalsection 150, or vice versa. To detach the proximal section 150 from thefirst distal section 142, the user may provide a force, through bending,pulling, rotating, or combination thereof, sufficient to tear along theperforations 194. The proximal section 150 may be detached from thefirst distal section 142 after mounting or installing the tool 24 on thesurgical device 28. The distal end 30 of the tool 24, including the head36, may remain safely packaged in the casing 152 subsequent todetachment of the proximal section 150 from the first distal section142.

Example methods of mounting the elongate tool 24 on the surgical device28 are also disclosed. FIG. 11 shows the robot R having an end effectorEE, which includes a non-limiting example of the surgical device 28. Itis to be understood the methods described herein may be applicable toany number and type of tools and surgical devices, and the surgicaldevice 28 need not include the robot R and/or the end effector EE. Incertain embodiments, the packaging system 20 and example methods may beutilized to mount the tool 24 to a handheld powered surgical device suchas a bone drill, oscillating saw, and the like. In other embodiments,the tool 24 may be mounted to a handheld and non-powered surgical devicesuch as a scalpel, an endoscope, and the like. The tool 24 need notinclude a cutting accessory with sharp features. Further, the examplemethods of mounting the tool 24 may not require that the tool 24 need besterilized. FIGS. 13-22 show a representative example of the endeffector EE to describe the methods of mounting the tool 24 on thesurgical device 28, and the representative example should not beconstrued as limiting.

The tool 24 includes the distal end 30 opposite the proximal end 32. Themethod may include providing the distal end 30 of the tool 24 within adistal cavity defined between the first distal section 42, 142 and thesecond distal section 44, 144. In certain embodiments, the distal cavitymay be defined as the combination of the cavity 54, 154 of the firstdistal section 42, 142 and the cavity 56, 156 of the second distalsection 44, 144. The distal cavity is referenced in FIGS. 3 and 7 asreference numeral 98 and in FIG. 8 as reference numeral 198.

Referring to FIG. 12, the tool 24 is disposed within the segmentedpackaging body 22, 122. FIGS. 12-22 show the packaging body 122 of theembodiment illustrated in FIGS. 8-10. It is to be understood the examplemethods may be similarly performed with the embodiment illustrated inFIGS. 1-7. The packaging body 22, 122 including the tool 24 is initiallypositioned away from the end effector EE. The packaging body 22, 122 maybe disposed with secondary packaging 26 such as the sealed pouch or theblister pack. Example methods may include removing the packaging body22, 122 from the secondary packaging 26.

With concurrent reference to FIGS. 3 and 8, FIG. 12 shows the packagingbody 22, 122 in the first configuration and the packaging configuration.The first configuration includes the first distal section 42, 142 andthe second distal section 44, 144 positioned in the abuttingrelationship such that the distal end 30 of the tool 24 is encased inthe casing 52, 152. In the first configuration, the distal end 30 of thetool 24 is disposed within the cavity 54, 154 of the first distalsection 42, 142 and the proximal end 32 of the tool 24 is disposedwithin the cavity 86, 186 of the proximal section 50, 150. The primarysurface 58, 158 of the first distal section 42, 142 and the primarysurface 60, 160 of the second distal section 44, 144 may besubstantially parallel in the first configuration. The packagingconfiguration includes the proximal end 32 of the tool 24 disposedwithin the cavity 86, 186 of the proximal section 50, 150. The primarysurface 58, 158 of the first distal section 42, 142 and the primarysurface 88, 188 of the proximal section 50, 150 may be substantiallycoplanar in the packaging configuration. The packaging configuration mayfurther be associated with the packaging body 22, 122, being in thefirst configuration as reflected in FIGS. 3, 8 and 12.

The user grasps the packaging body 22, 122 with, for example, the righthand RH and the left hand LH as shown in FIG. 13. Since the proximal end32 of the tool 24 is to be mounted on the end effector EE, the user maygrasp the packaging body 22, 122 by the casing 52, 152 with the proximalsection 50, 150 of the packaging body 22, 122 oriented towards the endeffector EE. FIG. 13 shows the user grasping the casing 52, 152 with theleft hand LH and the proximal section 50, 150 with the right hand RH.While holding the packaging body 22, 122, the method includesarticulating the proximal section 50, 150 about the proximal boundary48, 148 relative to the first distal section 42, 142 to remove theproximal end 32 of the tool 24 from the cavity 86, 186 of the proximalsection 50, 150. FIG. 14 shows the user articulating the proximalsection 50, 150 with the right hand RH while supporting the casing 52,152 with the left hand LH. The user may pinch between a thumb and indexfinger the casing 52, 152 so as to maintain the casing 52, 152 in thefirst configuration and avoid inadvertent decoupling of the first distalsection 42, 142 and the second distal section 44, 144. The relativearticulation exposes the proximal end 32 of the tool 24.

The relative articulation may be imparted by the left hand LH of theuser. The proximal section 50, 150 may pivot about the living hinge 92,192 at the proximal boundary 48, 148, and the cutouts 80, 180 mayfacilitate the pivoting. The pivoting of the proximal section 50, 150relative to the first distal section 42, 142 to expose the proximal end32 of the tool 24 includes moving the packaging body 22, 122 from thepackaging configuration to the installation configuration.

Referring to FIGS. 14 and 15, the proximal end 32 of the tool 24 ismounted on the surgical device 28 while the distal end 30 of the tool 24remains disposed within the distal cavity 98, 198 in the casing 52, 152.In other words, the tool 24 is installed while the packaging body 22,122 is in the first configuration and the installation configuration.FIG. 14 shows the step of mounting includes inserting the proximal end32 of the tool 24 within the end effector EE. The packaging body 22, 122is configured to be grasped by the user when the tool 24 is mounted onthe surgical device 28 while the packaging body 22, 122 is in theinstallation configuration as to avoid user contact with the tool 24.FIG. 15 shows the user slidably moving the tool 24 into a desiredengagement with the end effector EE while supporting the packaging body22, 122. The user is supporting the casing 52, 152 with the left hand LHand the proximal section 50, 150 with the right hand RH as the shaft 38of the tool 24 is slidably received with the end effector EE.

After mounting the proximal end 32 of the tool 24 on the surgical device28, the method may further include the step of detaching the proximalsection 50, 150 from the first distal section 42, 142 at the proximalboundary 48, 148. The proximal boundary 48, 148 includes theperforations 94, 194 to facilitate detaching the proximal section 50,150 from the first distal section 42, 142 at the perforations 94, 194.Subsequent to detachment of the proximal section 50, 150, the remainderof the packaging body 22, 122 assumes the configuration shown in FIG.18.

In another example method, the proximal section 50, 150 may be detachedfrom the first distal section 42, 142 prior to mounting or installingthe tool 24 on the surgical device 28. Referring to FIGS. 16 and 17, thecasing 52, 152 is shown without the proximal section 50, 150. The userdetaches the proximal section 50, 150 from the first distal section 42,142 at the perforations 94, 194. With one or both of the right hand RHand the left hand LH, the user mounts the proximal end 32 of the tool 24on the surgical device 28. FIG. 16 shows the user supporting the casing52, 152 with both the right hand RH and the left LH, and FIG. 17 showsthe user supporting the casing 52, 152 with the left hand LH. The usermay remove one of the hands RH, LH after a portion of the shaft 38 ofthe tool 24 is confidently within the end effector EE such that suitableengagement is ensured. The right hand RH of the user is now free toperform any other number of tasks related or unrelated to mounting thetool 24 on the surgical device 28. The packaging body 22, 122 assumesthe configuration shown in FIG. 18.

In certain embodiments, the method further includes articulating one ofthe first distal section 42, 142 and the second distal section 44, 144about the distal boundary 46, 146 relative to the other to expose atleast a portion of the distal end 30 of the tool 24. FIGS. 19 and 20show the user moving the packaging body 22, 122 from the firstconfiguration to the second configuration. In the second configuration,the first distal section 42, 142 and the second distal section 44, 144are in a non-abutting relationship. Stated simply, the user is openingthe casing 52, 152 encasing the distal end 30 of the tool 24. In theillustrative embodiment of FIG. 16, the proximal section 50, 150 is nolonger coupled to the first distal section 42, 142 before the packagingbody 22, 122 is moved from the first configuration to the secondconfiguration.

To articulate one of the first distal section 42, 142 and the seconddistal section 44, 144 about the distal boundary 46, 146, the user maygrasp the first distal section 42, 142 and pinch or grasp a portion ofthe second distal section 44, 144, such as with the finger grips 76,176. The step of articulating may further include decoupling thecouplers 68, 168. The force applied by the user to the second distalsection 44, 144 overcomes the interference fit provided by the couplers68, 168 (see FIG. 18). The living hinge 62, 162 and/or the cutouts 74,174 facilitate the relative pivoting between the first distal section42, 142 and the second distal section 44, 144 at the distal boundary 46,146. The user removes the other one of the first distal section 42, 142and the second distal section 44, 144 from the distal end 30 of the tool24. The user removes the packaging body 22, 122 from the head 36 of thetool 24 with sufficient clearance to avoid contamination. The head 36 ofthe tool 24 is now exposed and ready for use during a surgicalprocedure. It is to be appreciated that the user has not touched thetool 24 in any significant manner, and the head 36 of the tool 24 wasshielded from contamination.

In another example method, the user may wish to delay between the stepof mounting the tool 24 on the surgical device 28 and/or removing thepackaging body 22, 122 to expose the distal end 30 of the tool 24. Forexample, an operating room technician may mount the tool 24 on the endeffector EE well in advance of the surgical procedure. For any desiredamount of time, the packaging body 22, 122 may remain in theconfiguration shown in FIG. 18. The remainder of the packaging body 22,122 is in the first configuration such that the first distal section 42,142 and the second distal section 44, 144 are in the abuttingrelationship. The head 36 of the tool 24 remains secured and protectedwithin the casing 52, 152 after the tool 24 is mounted on the surgicaldevice 28. Should inadvertent contact occur with the tool 24, the riskof contamination and/or injury to the user and/or surgical device 28 isgreatly reduced.

Once desired, the casing 52, 152 may be removed from the tool 24 toexpose the distal end 30 of the tool 24. After the step of detaching theproximal section 50, 150 from the first distal section 42, 142, one ofthe first distal section 42, 142 and the second distal section 44, 144is articulated relative to one another about the distal boundary 46, 146to expose the distal end 30 as described. In the illustrative embodimentshown in FIGS. 19 and 20, the user may grasp the first distal section42, 142 with the left hand LH and the second distal section 44, 144 withthe right hand RH. The casing 52, 152 is sufficiently opened and theuser removes the remainder of the packaging body 22, 122 from the head36 of the tool 24 with sufficient clearance to avoid contamination. Thehead 36 of the tool 24 is now exposed and ready for use.

At any point prior to, during, and/or after the surgical procedure, thecasing 52, 152 may be reattached to the tool 24 so as to secure andprotect the head 36 of the tool 24 within the casing 52, 152. In oneexample, the tool 24 may need to be removed from the surgical device 28and/or mounted to another surgical device 28. In another example, anintermediate portion of the surgical procedure may not require the tool24, during which the tool 24 is protected from inadvertent contactand/or contamination. In still another example, an earlier portion ofthe surgical procedure requiring the tool 24 has been completed, and thetool 24 is protected for the remainder of the procedure, or discarded.Any number of reasons for reattaching the casing 52, 152 to the tool 24are contemplated.

The method may further include the step of moving the casing 52, 152from the second configuration to the first configuration, such as afterit had previously been removed from the distal end 30 of the tool 24.The method may further include the step of articulating one of the firstdistal section 42, 142 and second distal section 44, 144 about thedistal boundary 46, 146 relative to the other one of the first distalsection 42, 142 and second distal section 44, 144 to prevent exposure ofat least a portion of the distal end 30 of the tool 24. With FIGS. 21and 22 as example, the user supports the first distal section 42, 142with the left hand LH and the second distal section 44, 144 with theright hand RH. The user moves the casing 52, 152 proximate the distalend 30 of the tool 24 with the first distal section 42, 142 and thesecond distal section 44, 144 positioned on opposite sides of the tool24. The relative articulation between the first distal section 42, 142and the second distal section 44, 144 is imparted by the user to movethe first distal section 42, 142 and the second distal section 44, 144towards one another. The distal end 30 of the tool 24 is received in oneor both of the cavities 54, 56, 154, 156. FIG. 22 shows the userapplying a compressive force to the first distal section 42, 142 and thesecond distal section 44, 144 to engage the couplers 68, 168. Theinterference fit generated by the engagement of the couplers 68, 168causes the casing 52 to securely encase the distal end 30 of the tool24. The packaging body 22, 122 reassumes the configuration shown in FIG.18. It is to be understood that the casing 52, 152 may be decoupled andcoupled to the tool 24 as many times as needed prior to, during, andafter surgical procedure.

Example methods of assembling the packaging system 20 of the presentdisclosure are disclosed. The packaging body 22, 122 may be manufacturedby thermoforming or another suitable manufacturing process. Withreference to FIG. 5, following manufacture the first distal section 42,142 and second distal section 44, 144 may be positioned in anon-abutting relationship with the primary surface 58, 158 of the seconddistal section 44, 144 and the primary surface 88, 188 of the proximalsection 50, 150 coplanar.

The method further includes the step of inserting the tool 24 into thepackaging body 22, 122. The tool 24 is disposed within the cavity 54,154 of the first distal section 42, 142 and the cavity 86, 186 of theproximal section 50, 150. More specifically, the distal end 30 of thetool 24, including the head 36, is disposed within the cavity 54, 154 ofthe first distal section 42, 142, and the shaft 38 of the tool 24,including the proximal end 32, is disposed within the cavity 86, 186 ofthe proximal section 50, 150. The packaging body 22, 122, assumes thesecond configuration and the packaging configuration as described. Morespecifically, the first distal section 42, 142 and second distal section44, 144 are positioned in a non-abutting relationship, thereby exposinga portion of the distal end 30 of the tool 24, and the proximal end 32of the tool 24 is disposed within the cavity 86, 186 of the proximalsection 50, 150.

The casing 52, 152 may be moved from the second configuration to thefirst configuration. The method may further include the step ofarticulating one of the first distal section 42, 142 and second distalsection 44, 144 about the distal boundary 46, 146 relative to the otherone of the first distal section 42, 142 and second distal section 44,144 to prevent exposure at least a portion of the distal end 30 of thetool 24. The packaging body 22, 122, assumes the first configurationshown in FIG. 3. The packaging body 22, 122 remains in the packagingconfiguration. Secondary packaging 26 may be provided and adapted toreceive the packaging body 22, 122. Example methods may includedisposing the packaging body 22, 122 within the secondary packaging 26.

II. Packaging System Enabling Tool Rotation for Alignment

FIGS. 23 and 25 show a packaging system 220 including a packaging body222 in accordance with another example, wherein the packaging body 222is designed to mechanically facilitate installation of the tool 124, andin particular, where the tool 124 needs to rotate to install to thesurgical device 28.

Like components of the packaging body 22, 122 of the previouslydescribed embodiments are identified with reference numerals increasedby multiples of one hundred (100). Disclosure for the present example ofthe packaging body 222 abbreviated from the previously describedembodiments is not to be construed as limiting unless specificallyindicated. Any functionality and features related to the packaging bodyin the previous sections can be fully applied to the packaging bodydescribed in this section.

The packaging body 222 is configured to removably receive the tool 124configured to be mounted on the surgical device 28. FIG. 24 showsanother example tool 124 with like components relative to the previouslydescribed embodiment of the tool 124 identified with reference numeralsincreased by a multiple of one hundred (100). The tool 124 includes adistal end 130 and a proximal end 132 opposite the distal end 130. Alength of the tool 124 is defined between the distal end 130 and theproximal end 132. A rotational axis 134 of the tool 124 may be definedbetween the distal end 130 and the proximal end 132. The length of thetool 124 is much greater than the width of the tool 124 such that thetool 124 may be defined as elongate. The tool 124 of FIG. 23 is circularin cross section and is configured to rotate about an axis of symmetry.The proximal end 132 is configured to be coupled to the surgical device28, for example, the surgical robot R having the end effector EE (seeFIG. 11). Alternatively, the surgical device 28 can be other mounted orhand-held surgical devices, such as those described above, or others notspecifically described herein. FIG. 24 shows the tool 124 as a drill bitwith a working portion 136 near or at the distal end 130, and a shaft orshank 138 extending to the distal end 130. The working portion 136 mayinclude flutes extending proximally from the distal end 130.

The tool 124 may include alignment features 131 at or near the proximalend 132. With continued reference to FIG. 24, the alignment features 131are coupled to the shank 138 and may be spaced part from the proximalend 132. As is described in greater detail below, the alignment features131 are configured to facilitate rotationally locking the tool 124 tothe surgical device 28 (or tool receiving portion of the surgicaldevice) so that the surgical device 28 can rotate the tool 124 uponattachment. In order to axially lock the tool 124 to the surgical device28, the tool 124 may include one or more resilient arms, generallyindicated at 133. The resilient arms 133 may define the proximal end 132of the tool 124. One suitable interface for facilitating theaforementioned rotational and axial locking is disclosed in commonlyowned International Publication No. PCT/IB2018/056251, filed Aug. 17,2018, the entire contents of which are hereby incorporated by reference.Secondary packaging 26 (see FIG. 1), such as the sealed pouch, theblister pack, or the like, may be provided and configured to receive thepackaging body 222.

Returning to FIGS. 23 and 25, the packaging body 222 includes the casing252. The casing 252 can be a permanently enclosed casing. In otherwords, the casing 252 would need to be partially or entirely destroyedor deformed in order to open the casing. Alternatively, the casing 252can be configured to be freely opened and closed, as needed. In oneexample, the casing 252 can be configured as a clamshell casing, whichmay further include the first distal section 242 coupled to the seconddistal section 244 in a pivoting manner, such as any combination of theconfigurations described in the previous section. Alternatively, thecasing 252 may include the removable couplers of the previouslydescribed embodiments of the packaging body 22, 122.

When the casing 252 is permanently enclosed, the casing 252 may compriseone integrally formed part, or may comprise several different parts. Inone example, the first distal section 242 and the second distal section244 may be joined together in a permanent manner. For example, theillustrated embodiment shows the primary surfaces 258, 260 of the firstdistal section 242 and the second distal section 244, respectively,joined through with high frequency welding. FIGS. 23 and 25 show awelding interface 261 on each of the primary surfaces 258, 260 andarranged in a generally U-shaped configuration. Overcoming the weldinginterface 261 may result in plastic deformation of one of the first andsecond distal sections 242, 244. Other suitable permanent joining meansare contemplated, for example rivets or other fasteners, adhesives, etc.

The casing 252 is configured to receive the distal end 130 of the tool124. The casing 252 may define the cavity 254, 256 disposed in at leastone of the first and second distal sections 242, 244, respectively(collectively defined as cavity 255). With reference to FIG. 25, thecavity 254 may defined within the primary surface 258 of the firstdistal section 242, and the cavity 256 may defined within the primarysurface 260 of the second distal section 244. The cavities 254, 256 ofeach of the first and second distal sections 142, 144 may be inalignment so as to receive the working portion 136 of the tool 124.Further, the cavity 255 may be substantially contoured to a distalregion of the tool 124 such that a portion of the shank 138 is at leastpartially encased within the casing 252. FIG. 25 shows the cavities 254,256 as being elongate.

The packaging body 222 may include the proximal section 250 coupled tothe first distal section 242 at the proximal boundary 248. The proximalsection 250 defines the cavity 286 sized to receive a proximal portionof the shank 138 of the tool 124 including the alignment features 131and the resilient arms 133. The tool 124 may be secured within thecavity 286 with the one or more shaft couplers 290 which include, forexample, the protrusions with the counter posing recesses to provide theinterference fit to the shank 138 of the tool 124. The interference fitmay be provided by a small amount of elastic deformation of the shaftcoupler 290 that occurs as the tool 124 is urged within the cavity 286of the proximal section 250.

In manners previously described, the proximal section 250 is configuredto move between the packaging configuration and the installationconfiguration. The packaging configuration includes the proximal end 132of the tool 124 disposed within the cavity 286 of the proximal section250. The installation configuration includes pivoting the proximalsection 250 relative to the casing 252, thereby exposing the proximalend 132 of the tool 124 outside the cavity 286 of the proximal section250. The living hinge 292 and the cutouts 280 facilitate the relativepivoting between the casing 252 and the proximal section 250 at theproximal boundary 248. Moreover, the packaging body 222 may include theperforations 294 at the proximal boundary 248 configured to facilitatedetachment of the casing 252 from the proximal section 250, or viceversa. The proximal section 250 may be detached from the casing 252before or after mounting or installing the tool 124 on the surgicaldevice 28. The distal end 130 of the tool 124, including the workingportion 136, may remain safely packaged in the casing 252 subsequent todetachment of the proximal section 250 from the first distal section242.

Of particular interest to the present embodiment is providing forself-aligned mounting of the tool 124 on the surgical device 28 withoutrequiring undue manipulation or deformation of the casing 252. Withcontinued reference to FIGS. 23 and 25, the packaging system 220includes a sleeve 223 retained by the casing 252. The sleeve 223 isdisposed within the cavity 255 of the casing 252. In particular, each ofthe cavities 254, 256 are positioned and shaped such that, with thefirst and second distal sections 242, 244 coupled to one another, atleast a portion of the sleeve 223 is situated within the cavity 255. Forreasons to be explained in greater detail, the cavity 255 is contouredto the sleeve 223, but sized to permit rotation of the sleeve 223 withinthe casing 252. In other words, with each of the cavities 254, 256 beingsemi-cylindrical, an inner diameter of the cavity 255 is greater thanthe outer diameter of the sleeve 223 to permit for rotation of thesleeve 223 relative to the casing 252. In alternative examples where thecasing 252 is of one integrally formed part (without separate sections242, 244), the cavity can be defined by the integrally formed part tocapture the sleeve 223.

A combined force (e.g., static, frictional, compressive, etc.) thatretains the sleeve 223 to the tool 124 is greater than a combined forcethat retains the sleeve 223 to the casing 242. For this reason, the tool124 and sleeve 223 can freely rotate together relative to the casing 242when the tool 124 is rotated relative to the casing 242. Meanwhile, forany rotational position of the tool 124, the sleeve 223 remains retainedto the tool 124, until the casing 242 and the tool 124 are linearlyseparated along the axis of rotation.

The sleeve 223 may include a first end 225, a second end 227 oppositethe first end 225, and a lumen 229 at least partially defined betweenthe first and second ends 225, 227. FIGS. 23 and 25 show the lumen 229extending from the first end 225 to the second end 227. In one example,the sleeve 223 and the lumen 229 are cylindrical. In another example,the sleeve 223 and/or lumen 229 may be spherical, semi-spherical, or anyother shape that has an axis of symmetry for permitting rotation. Thelumen 229 is sized to receive the working portion 136 of the tool 124,and more particularly sized to engage the working portion 136 of thetool 124 with an interference fit. In other words, with the sleeve 223disposed within the cavity 254, 256 and the tool 124 engaging the sleeve223, a rotation imparted to the shank 138 of the tool 124 causes thetool 124 and the sleeve 223 to rotate within the casing 252.

The casing 252 defines an opening 231 in communication with the cavity255. The shank 138 of the tool 124 extends out of the opening 231towards the proximal section 250, as shown in FIG. 23. The opening 231may be formed between complementary ends of the cavities 254, 256 of thefirst and second distal sections 242, 244, respectively. With particularreference to FIG. 25, the cavity 255 may be elongate and further definedby a distal cavity portion 255 d and a proximal cavity portion 255 p.The distal cavity portion 255 d extends between a closed cavity end 233defined by the casing 252, and a stepped surface 235. The proximalcavity portion 255 p extends between the stepped surface 235 and theopening 231. As best shown in FIG. 25, the stepped surface 235 isarranged such that a width of the proximal cavity portion 255 p isnarrower than a width of the distal cavity portion 255 d. The sleeve 223is disposed within the distal cavity portion 255 d. In other words, thefirst end 225 of the sleeve 223 is positioned adjacent the closed cavityend 233 of the cavity 255, and the second end 227 of the sleeve 223 ispositioned adjacent the stepped surface 235. With the outer diameter ofthe sleeve 223 greater than the width of the proximal cavity portion 255p, the sleeve 223 is retained within the casing 252. More specifically,the sleeve 223 is prevented from being removed from the casing 252through the proximal cavity portion 255 p and the opening 231,particularly during removal of the tool 124 from the sleeve 223 in amanner to be described. The arrangement may result in the sleeve 223being substantially encased within the casing 252. As opposed to thestepped surface 235, a taper or other barrier may be provided tofacilitate retention of the sleeve 223 within the casing 252. While thesleeve 223 is retained within the casing 252, the outer diameter of thetool 124 is less than the width of the proximal cavity portion 255 psuch that the tool 124 is removable from the casing 252 through theopening 231.

This casing configuration provides continuous protection from theworking portion 136 of the tool 124 simultaneously while enabling thetool 124 to be retained and rotatable within the casing 252 duringinstallation. Furthermore, when the casing 252 is permanently closed,the working portion 136 can be withdrawn from the casing 252 andreinserted into the casing 252 as needed through the opening 231,without requiring re-assembly or causing destruction of the casing 252.

As mentioned, the working portion 136 of the tool 124 engages the sleeve223 with an interference fit. The length of the sleeve 223 and the lumen229 may be sized to receive an entirety of the flutes of the workingportion 136 of the drill bit of FIG. 24. At the same time, however, theinterference fit is capable of being overcome with sufficient forceapplied to the casing 252 relative to the tool 124, or vice versa,without the flutes removing material from the lumen 229 of the sleeve223 (e.g., galling). In certain embodiments, the packaging body 222 isformed from a first material, and the sleeve 223 is formed form a secondmaterial different than the first material. The first and secondmaterials may be plastics or other suitable polymer, metal, composite,and the like, with the second material forming the sleeve 223 beingsufficiently more robust to prevent the galling during removal of theworking portion 136 from the sleeve 223. A kit may be provided includingthe packaging body 222, the sleeve 223, and the tool 124.

FIGS. 26-28 show a packaging system 320 including a packaging body 322in accordance with another example, wherein the packaging body 322 isdesigned to mechanically facilitate installation of the tool 124including the alignment features 131 for rotationally locking the tool124 to the surgical device 28 (or tool receiving portion of the surgicaldevice) so that the surgical device 28 can rotate the tool 124 uponattachment. Like components of the packaging body 22, 122, 222 of thepreviously described embodiment(s) are identified with referencenumerals increased by multiples of one hundred (100). Disclosure for thepresent example of the packaging body 322 abbreviated from thepreviously described embodiments is not to be construed as limitingunless specifically indicated. Any functionality and features related tothe packaging body in the previous sections can be fully applied to thepackaging body described in this section.

FIGS. 26 and 27 show the packaging body 322 including the casing 352.The casing 352 can be a permanently enclosed casing. In other words, thecasing 352 would need to be partially or entirely destroyed or deformedin order to open the casing. When the casing 352 is permanentlyenclosed, the casing 352 may comprise one integrally formed part, or maycomprise several different parts. In one example, the first distalsection 342 and the second distal section 344 may be joined together ina permanent manner. For example, the illustrated embodiment shows theprimary surfaces 358, 360 of the first distal section 342 and the seconddistal section 344, respectively, joined through with high frequencywelding. FIGS. 26 and 28 show the welding interface 361 on each of theprimary surfaces 358, 360 and arranged in a generally U-shapedconfiguration. Overcoming the welding interface 361 may result inplastic deformation of one of the first and second distal sections 342,344. Other suitable permanent joining means are contemplated, forexample rivets or other fasteners, adhesives, etc. Alternatively, thecasing 352 can be configured to be freely opened and closed, as needed.In one example, the casing 352 can be configured as a clamshell casing,which may further include the first distal section 342 coupled to thesecond distal section 344 in a pivoting manner, such as any combinationof the configurations described in the previous section.

The packaging body 322 may include the couplers 368 for facilitatingassembly of the first and second distal sections 342, 344. The couplers368 may cooperate to align the second distal section 344 with the firstdistal section 342 prior to being joined through with high frequencywelding. Alternatively, the couplers 368 may operate by interference orfriction fit to facilitate the casing 352 being freely opened andclosed, as needed.

The casing 352 is configured to receive the distal end 130 of the tool124. The casing 352 may define the cavity 355 within at least one of thefirst and second distal sections 342, 344. With reference to FIG. 27,the cavity 355 may defined within the primary surface 358 of the firstdistal section 342, and may be substantially contoured to a distalregion of the tool 124 such that a portion of the shank 138 is at leastpartially encased within the casing 352.

The proximal section 350 defines the cavity 386 sized to receive aproximal portion of the shank 138 of the tool 124 including thealignment features 131 and the resilient arms 133. The tool 124 may besecured within the cavity 386 with the one or more shaft couplers 390which include, for example, the protrusions with the counter posingrecesses to provide the interference fit to the shank 138 of the tool124. The interference fit may be provided by a small amount of elasticdeformation of the shaft coupler 390 that occurs as the tool 124 isurged within the cavity 386 of the proximal section 350.

The proximal section 350 may be removably coupled to the casing 352, andin particular to the first distal section 342. FIG. 27 shows theproximal section 350 including a pair of lugs 397 extending from theprimary surface 388 of the proximal section 350, and a pair of cavities395 within the casing 352. The cavities 395 are sized to snugly andremovably receive the lugs 397. The cavities and lugs 395, 397 arecomplementarily positioned such that, when the lugs 397 are disposedwithin the cavities 395, the sleeve 322 is aligned with the cavity 386of the proximal section 350 in the arrangement shown in FIG. 26. Thealignment facilitates the distal region of the tool 124 being disposedwithin the sleeve 323, and a proximal region of the tool 124 beingdisposed within the cavity 386 of the proximal section 350.

The cavities and lugs 395, 397 may or may provide interferenceengagement to maintain coupling of the casing 352 and the proximalsection 350 until the user affirmatively manipulates the packaging body322 to overcome the interference engagement. In one example, cavitiesand lugs 395, 397 do not provide a meaningful friction fit, but ratherthe tool 124 cooperates with the packaging body 322 to maintain couplingof the casing 352 and the proximal section 350. As mentioned, the distalend 130 of the tool 124 is disposed within the casing 352, and theproximal portion of the shank 138 of the tool 124 is disposed within theproximal section 350. More particularly, the sleeve 323 provides aninterference fit with the distal end 130 of the tool 124, and the shaftcouplers 390 provide an interference fit with the shank 138 of the tool124. Thus, the tool 124 itself may effectively provide the structure“bridges” the casing 352 and the proximal section 350 to couple thesame, with the cavities and lugs 395, 397 preventing any relativemovement. For example, the cavities and lugs 395, 397 may preventinadvertent movement of the proximal section 350 relative to the casing352 along the tool axis 134 (see FIG. 24), and the cavities and lugs395, 397 along with the primary surface 388 of the proximal section 350may prevent inadvertent rotation the proximal section 350 relative tothe casing 352 about the tool axis 134.

The proximal section 350 is removably coupled to the casing 352. Todecouple the proximal section 350 from the casing 352, for example,prior to mounting or installing the tool 124 on the surgical device 28,the user may provide an input to the packaging body 322 tosimultaneously or sequentially overcome the interference engagementprovided by the shaft couplers 390, and further remove the lugs 397 fromwithin the cavities 395. For example, the user may support the casing352 with one hand and provide a downward force to the proximal section350 near the distal end 132 of the tool 124. The force may the shaftcouplers 390 to sequentially disengage in the distal direction (theproximal section 350 may flex to facilitate the disengagement), and oncethe shaft couplers 390 are disengaged, the lugs 397 may be removed fromwithin the cavities 395 with relative ease. The distal end 130 of thetool 124, including the working portion 136, may remain safely packagedin the casing 352 subsequent to detachment of the proximal section 350from the first distal section 342.

With continued reference to FIGS. 26-28, the packaging system 320includes the sleeve 323 retained by the casing 352. The sleeve 323 isdisposed within the cavity 355 of the casing 352. In particular, withthe first and second distal sections 342, 344 coupled to one another,either permanently or removably, at least a portion of the sleeve 323 issituated within the cavity 355. For reasons to be explained in greaterdetail, the cavity 355 is contoured to the sleeve 323, but sized topermit rotation of the sleeve 323 within the casing 352. In other words,the cavity 355 may be at least substantially cylindrical, an innerdiameter of the cavity 355 is greater than the outer diameter of thesleeve 323 to permit for rotation of the sleeve 323 relative to thecasing 352. In alternative examples where the casing 352 is of oneintegrally formed part (without separate sections 342, 344), the cavitycan be defined by the integrally formed part to capture the sleeve 323.

A combined force (e.g., static, frictional, compressive, etc.) thatretains the sleeve 323 to the tool 124 is greater than a combined forcethat retains the sleeve 323 to the casing 342. For this reason, the tool124 and sleeve 323 can freely rotate together relative to the casing 342when the tool 124 is rotated relative to the casing 342. Meanwhile, forany rotational position of the tool 124, the sleeve 323 remains retainedto the tool 124, until the casing 342 and the tool 124 are linearlyseparated along the axis of rotation.

The sleeve 323 may include a first end 325, a second end 327 oppositethe first end 325, and a lumen 329 at least partially defined betweenthe first and second ends 325, 327. FIGS. 27 and 28 show the lumen 329extending from the first end 325 to the second end 327. In one example,the sleeve 323 and the lumen 329 are cylindrical. In another example,the sleeve 323 and/or lumen 329 may be spherical, semi-spherical, or anyother shape that has an axis of symmetry for permitting rotation. Thelumen 329 is sized to receive the working portion 136 of the tool 124,and more particularly sized to engage the working portion 136 of thetool 124 with an interference fit. In other words, with the sleeve 323disposed within the cavity 355 and the tool 124 engaging the sleeve 323,a rotation imparted to the shank 138 of the tool 124 causes the tool 124and the sleeve 323 to rotate within the casing 352.

The casing 352 defines an opening 331 in communication with the cavity355. The shank 138 of the tool 124 is configured to extend out of theopening 331 towards the proximal section 350. The opening 331 may beformed between the first and second distal sections 342, 344,respectively. With particular reference to FIG. 25, the cavity 355 maybe elongate and further defined by a distal cavity portion 355 d and aproximal cavity portion 355 p. The distal cavity portion 355 d extendsbetween a closed cavity end 233 defined by the casing 352, and a steppedsurface 335. The proximal cavity portion 355 p extends between thestepped surface 335 and the opening 331. As best shown in FIG. 28, thestepped surface 335 is arranged such that a width of the proximal cavityportion 355 p is narrower than a width of the distal cavity portion 355d. The sleeve 323 is disposed within the distal cavity portion 355 d. Inother words, the first end 325 of the sleeve 323 is positioned adjacentthe closed cavity end 333 of the cavity 355, and the second end 327 ofthe sleeve 323 is positioned adjacent the stepped surface 335. With theouter diameter of the sleeve 323 greater than the width of the proximalcavity portion 355 p, the sleeve 323 is retained within the casing 352.More specifically, the sleeve 323 is prevented from being removed fromthe casing 352 through the proximal cavity portion 355 p and the opening331, particularly during removal of the tool 124 from the sleeve 323.The arrangement may result in the sleeve 323 being substantially encasedwithin the casing 352. As opposed to the stepped surface 335, a taper orother barrier may be provided to facilitate retention of the sleeve 323within the casing 352. While the sleeve 323 is retained within thecasing 352, the outer diameter of the tool 124 is less than the width ofthe proximal cavity portion 355 p such that the tool 124 is removablefrom the casing 352 through the opening 331.

This casing configuration provides continuous protection from theworking portion 136 of the tool 124 simultaneously while enabling thetool 124 to be retained and rotatable within the casing 352 duringinstallation. Furthermore, when the casing 352 is permanently closed,the working portion 136 can be withdrawn from the casing 352 andreinserted into the casing 352 as needed through the opening 331 withoutrequiring re-assembly or causing destruction of the casing 352.

As mentioned, the working portion 136 of the tool 124 engages the sleeve323 with an interference fit. The length of the sleeve 323 and the lumen329 may be sized to receive an entirety of the flutes of the workingportion 136 of the drill bit of FIG. 26. At the same time, however, theinterference fit is capable of being overcome with sufficient forceapplied to the casing 352 relative to the tool 124, or vice versa,without the flutes removing material from the lumen 329 of the sleeve323 (e.g., galling). In certain embodiments, the packaging body 322 isformed from a first material, and the sleeve 323 is formed form a secondmaterial different than the first material. The first and secondmaterials may be plastics or other suitable polymer, metal, composite,and the like, with the second material forming the sleeve 323 beingsufficiently more robust to prevent the galling during removal of theworking portion 136 from the sleeve 323. A kit may be provided includingthe packaging body 322, the sleeve 323, and the tool 124.

Example methods of mounting the elongate tool 124 on the surgical device28 with the packaging system 220, 320 are described with reference toFIGS. 30-33. The tool 124 is disposed within the packaging body 222,322, and the packaging body 222, 322 including the tool 124 is initiallypositioned away from the surgical device 28, in this example the endeffector. Again, the surgical device 28 can be a hand-held deviceinstead of an end effector. FIG. 30 shows the packaging body 222 beingmoved from the packaging configuration with the proximal end 132 of thetool 124 disposed within the cavity 286 to the installationconfiguration. The user grasps the packaging body 222 with, for example,the right hand RH and the left hand LH as shown in FIG. 30. Whileholding the packaging body 222, the proximal section 250 is articulatedor bent about the proximal boundary 248 relative to the casing 252 toremove or expose the proximal end 132 of the tool 124 from the cavity286 of the proximal section 250. The relative articulation exposes theorientation features 131 of the tool 124.

The proximal end 132 of the tool 124 is mounted on the surgical device28 while the distal end 130 of the tool 124 remains disposed within thesleeve 223 retained within the casing 252. FIGS. 30 and 31 show the userslidably moving the tool 124 into a desired engagement with the surgicaldevice 28 while supporting the casing 252. In this example, the user issupporting the casing 252 with the left hand LH and the proximal section250 with the right hand RH as the shank 138 of the tool 124 is slidablyreceived by the surgical device 28.

As the proximal end 132 is directed into the surgical device 28, theworking portion 136 of the tool 124 remains within the sleeve 223. Thealignment features 131 engage complementary alignment features (notshown) associated with the surgical device 28. The initial engagement ofthe complementary alignment features 131 are configured to impartrotation to the tool 124 to provide for further advancement of the tool124 within the surgical device 28, as detailed in commonly ownedInternational Publication No. PCT/IB2018/056251, filed Aug. 17, 2018,the entire contents of which are hereby incorporated by reference. Therotation of the tool 124 imparts like rotation to the sleeve 223 withinthe casing 252 owing to the interference fit between the working portion136 and the lumen 229 of the sleeve 223 (represented as arrow 237 inFIG. 31). In other words, the self-aligning causes rotation of the tool124 and the sleeve 223 relative to the casing 252. The advantages of thepackaging system 220 are readily realized as providing for self-alignedmounting of the tool 124 on the surgical device 28 without requiringmanual rotation or further manipulation of the shank 138 of the tool 124and/or the casing 252 being grasped by the user. After mounting the tool124 on the surgical device 28, the method may further include the stepof detaching the proximal section 250 from the casing 252 at theproximal boundary 248. The proximal boundary 248 includes theperforations 294 to facilitate detaching the proximal section 250.

In another example method shown in FIGS. 32 and 33, the proximal section350 may be decoupled from the casing 352 prior to mounting or installingthe tool 124 on the surgical device 28 in manners previously described.With one or both of the right hand RH and the left hand LH, the usermounts the proximal end 132 of the tool 124 on the surgical device 28.FIG. 32 shows the user supporting the casing 352 with both the righthand RH and the left LH, and the user may remove one of the hands RH, LHafter a portion of the shank 138 of the tool 124 is confidently withinthe surgical device 28 such that suitable engagement is ensured. Again,as the proximal end 132 is directed into the surgical device 28, thealignment features 131 engage complementary alignment features the tool124 and the sleeve 332 rotate within the casing 352 (represented asarrow 339 in FIG. 33).

The user may wish to delay between the step of mounting the tool 124 onthe surgical device 28 and/or removing the packaging body 222, 322 toexpose the distal end 130 of the tool 124. The working portion 136 ofthe tool 124 remains secured and protected within the casing 252, 352after the tool 124 is mounted on the surgical device 28. Shouldinadvertent contact occur with the tool 124, the risk of contaminationand/or injury to the user and/or surgical device 28 is greatly reduced.Once desired, the casing 252, 352 (and the sleeve 223, 323) may beremoved from the tool 124 to expose the working portion 136 of the tool124. The user may apply an input to the casing 252, 352 to apply a forceparallel to the axis 134 of the tool 124 (see FIGS. 24 and 26). Theinterference engagement between the tool 124 and the sleeve 223, 323 isovercome, and the sleeve 223, 323 is slidably removed from the workingportion 136. Owing to the aforementioned stepped surface 235, 335providing the proximal cavity portion 255 p, 355 p that is narrower thanthe outer diameter of the sleeve 223, 323, the sleeve 223, 323 remainsdisposed within the cavity 255, 355 subsequent to removal of the tool124. The working portion 136 of the tool 124 is now exposed and readyfor use during a surgical procedure. It is to be appreciated that theuser has not touched the tool 124 in any significant manner, and theworking portion 136 of the tool 124 was shielded from contamination andto avoid injury. The above-described methods can be utilized with anyconfiguration of the packaging system that includes the sleeve 223, 323.

III. Indicia for Intuitive Operation of the Packaging System

With continued reference to FIGS. 26-28 ad further reference to FIG. 29,the packaging body 322 may include a finger grip 376 configured to begrasped by at least one finger of the user during manipulation of thepackaging body 322. Moreover, the finger grip 376 may be positioned,sized, and/or shaped in a manner to provide an indication to the user ofa proper manner to hold the packaging body 322 during insertion of thetool 124 on the surgical device 28. The finger grip 376 shown in FIGS.26-29 is a texturized feature representative of a thumb print of a humanhand. Further, the finger grip 376 is disposed on the primary surface360 of the second distal section 344 of the casing 352, which may beconsidered the uppermost surface of the packaging body 322. Owing to theoverall geometry of the packaging body 322, including the cavity 386 ofthe proximal section 350 opening upwardly, the user may be inclined tohold the primary surface 360 of the second distal section 344 upward,which assumes a natural position for the thumb (with one or more fingerssupporting an underside of the casing 352 opposite the primary surface360). Thus, the texturized feature representative of the thumb printprovides an indication for the user to position their thumb on thefinger grip 376 during insertion of the tool 124 on the surgical device28. Similarly, the texturized feature representative of the thumb printis generally oriented perpendicular to the tool axis 124, which, again,may be the most natural for the thumb with the packaging body 322 beingadvanced towards the surgical device 28 in along the tool axis 124. Itis appreciated that the texturized feature representative of the thumbprint may be included on any of the implementations of the packagingbody 22, 122, 222.

In certain implementations, at least a portion of the casing 352 may becolored differently than the proximal section 350. As best shown inFIGS. 27 and 28, the first distal section 342 is colored (represented byhorizontal hatchings indicative of the color blue), for example, formedfrom a colored thermoformed plastic. The second distal section 344and/or the proximal section 350 may be at least substantiallytranslucent, for example, clear. The coloring of the casing 352 mayprovide several advantages. First, the coloring may provide a visualindication of a location of the working portion 136 of the tool 124.Second, the coloring may provide an impression to the user that thecasing 352 is the primary functional component of the tool 124. In otherwords, the proximal section 350 being clear may indicate that theproximal section 350 is to be decoupled and discarded while the casingis to remain removably retained on the working portion 136 of the tool124 for mounting the tool 124 on the surgical device 28. The coloringmay also direct the user's attention to the texturized featurerepresentative of the thumb print, which in combination with thecoloring itself, may provide the user with an indication of the mannerby which to hold or manipulate the packaging body 322 to mount the tool124 on the surgical device 28. Third, the coloring may provide contrastwith the background environment once the tool 124 is mounted on thesurgical device 28. As previously described in detail, the workingportion 136 of the tool 124 may remain secured and protected within thecasing 352 after the tool 24 is mounted on the surgical device 28.Should inadvertent contact occur with the tool 124, the risk ofcontamination and/or injury to the user and/or surgical device 28 isgreatly reduced. Should the casing 352 be clear, for example, the tool124 (and casing 352) may be less noticeable to those moving about thesurgical suite. The contrast provided by the coloring to the casing 352may limit or prevent the inadvertent contact. It is appreciated that thecoloring feature may be included on any of the implementations of thepackaging body 22, 122, 222.

With particular reference to FIG. 29, a series of instructional markings399 may be disposed on the packaging body 322. The instructionalmarkings 399 may provide visual indication of steps for mounting thetool 124 on the surgical device 28. The instructional markings 399 maybe, for example, illustrations, pictures, or the like. FIG. 29 shows theinstructional markings disposed on the proximal section 350 andincluding five instructional markings 399 a-e each representative of astep of mounting the tool 124 on the surgical device 28. A first of theinstructional markings 399 a shows the user how to move the packagingbody 322 from the packaging configuration to the installationconfiguration, in particular, by articulating or bending the proximalsection 350 about the proximal boundary 348 relative to the casing 352to remove or expose the proximal end 132 of the tool 124. Additionallyor alternatively, first of the instructional markings 399 a shows how todecoupling and/or detaching the proximal section 350 from the casing352.

A second of the instructional markings 399 b shows the user how tosupport the casing 352. It is appreciated that the finger grip 376(i.e., the texturized feature representative of the thumb print) isshown in the second instructional marking 399 b to assist the user withidentifying the proper manner to grasp and orient the casing 352 and thetool 124, respectively.

A third and fourth of the instructional markings 399 c, 399 d shows theuser how to mount the proximal end 132 of the tool 124 on the surgicaldevice 28. An arrow shown on the fourth instructional markings 399 dindicates the shank 138 of the tool 124 is moved axially towards thesurgical device 28 (shown supported by one of the user's hands) toensure suitable engagement.

A fifth of the instructional markings 399 e shows the user how to exposethe working portion 136 of the tool 124. An arrow is indicative of theforce to be applied to the casing 352 to overcome the interferenceengagement between the tool 124 and the sleeve 323 to slidably removethe working portion 136. The working portion 136 of the tool 124 is nowexposed and ready for use during a surgical procedure. It is appreciatedthat the instructional markings 399 may be included on any of theimplementations of the packaging body 22, 122, 222.

From FIG. 29, it should also be appreciated that features from theembodiments of the packaging body 22, 122, 222, 322 may be combinedwithout limitation. FIG. 29 shows certain features from the embodimentof FIGS. 26-28 (e.g., the geometry of the proximal section 350 includingthe shaft couplers 390, geometry of the casing 352, and the finger grip376), and certain features from the embodiment of FIGS. 23 and 25 (e.g.,the living hinge 362 including the perforations 264, and the livinghinge 392 including the perforations 394), and certain features from theembodiment of FIGS. 3-10 (e.g., the casing 352 being the clamshellcasing). The embodiments discussed herein are not intended to beexhaustive or limit the invention to any particular form. Theterminology which has been used is intended to be in the nature of wordsof description rather than of limitation. Many modifications andvariations are possible in light of the above teachings and theinvention may be practiced otherwise than as specifically described.

What is claimed is:
 1. A packaging system for a tool that has a cuttingbur and a shaft, the packaging system comprising: a casing comprising adistal section defining a cavity configured to receive the cutting burof the tool; and a proximal section coupled to the distal section andbeing configured to receive the shaft of the tool, and the proximalsection being configured to detach from the distal section; wherein atleast a portion of the distal section comprises a colored indicator toprovide a visual indication of a location of the cutting bur of thetool; and wherein instructions are provided on the proximal section andthe instructions are configured to illustrate one or more steps forinstalling the tool to a surgical device.
 2. The packaging system ofclaim 1, wherein the colored indicator is colored differently than theproximal section.
 3. The packaging system of claim 1, wherein the distalsection and the proximal section are translucent.
 4. The packagingsystem of claim 1, wherein the distal section comprises: a first distalsection comprising a first boundary and a second boundary; a seconddistal section coupled to the first distal section at the firstboundary; the first and second distal sections being configured tocollectively define the cavity that receives the cutting bur; and thefirst and second distal sections being configured to detachably coupleto one another.
 5. The packaging system claim 4, wherein the seconddistal section is pivotable relative to the first distal section at thefirst boundary such that the first distal section and the second distalsection collectively provide a clamshell casing to the cutting bur ofthe tool.
 6. The packaging system of claim 4, wherein: one of the firstand second distal sections comprises a protrusion; the other one of thefirst and second distal sections comprises a recess configured toreceive the protrusion; and the first distal section and the seconddistal section are configured to detachably couple to one another byinterference fit between the protrusion and the recess.
 7. The packagingsystem of claim 4, wherein the proximal section is pivotably coupled tothe first distal section at the second boundary.
 8. The packaging systemof claim 7, further comprising a perforation at the second boundarybeing configured to facilitate detachment of the proximal section fromthe first distal section.
 9. The packaging system of claim 1, whereinthe at least a portion of the distal section that comprises the coloredindicator is formed of colored thermoformed plastic.
 10. The packagingsystem of claim 1, wherein the instructions provided on the proximalsection are further defined as visual instructions.
 11. The packagingsystem of claim 10, wherein the visual instructions compriseillustrations.
 12. The packaging system of claim 11, wherein the visualinstructions illustrate steps for installing the tool to the surgicaldevice.
 13. The packaging system claim 12, wherein one of theillustrated steps is configured to instruct a proper manner to grasp thedistal section for installing the tool to the surgical device.
 14. Thepackaging system of claim 13, wherein one of the illustrated steps isconfigured to instruct a proper insertion of the shaft into the surgicaldevice.
 15. A surgical kit comprising: a tool including a cutting burand a shaft; and a packaging system comprising: a casing comprising adistal section defining a cavity configured to receive the cutting burof the tool; and a proximal section coupled to the distal section andbeing configured to receive the shaft of the tool, and the proximalsection being configured to detach from the distal section; wherein atleast a portion of the distal section comprises a colored indicator toprovide a visual indication of a location of the cutting bur of thetool; and wherein instructions are provided on the proximal section andthe instructions are configured to illustrate one or more steps forinstalling the tool to a surgical device.
 16. The surgical kit of claim15, wherein the colored indicator is colored differently than theproximal section.
 17. The surgical kit of claim 15, wherein the distalsection comprises: a first distal section comprising a first boundaryand a second boundary; a second distal section coupled to the firstdistal section at the first boundary; the first and second distalsections being configured to collectively define the cavity thatreceives the cutting bur; and the first and second distal sections beingconfigured to detachably couple to one another. wherein the seconddistal section is pivotable relative to the first distal section at thefirst boundary such that the first distal section and the second distalsection collectively provide a clamshell casing to the cutting bur ofthe tool.
 18. The surgical kit of claim 17, wherein the proximal sectionis pivotably coupled to the first distal section at the second boundary,and further comprising a perforation at the second boundary beingconfigured to facilitate detachment of the proximal section from thefirst distal section.
 19. The surgical kit of claim 15, wherein theinstructions provided on the proximal section are further defined asvisual instructions that illustrate steps for installing the tool to thesurgical device.
 20. The surgical kit of claim 19, wherein: one of theillustrated steps is configured to instruct a proper manner to grasp thedistal section for installing the tool to the surgical device; and oneof the illustrated steps is configured to instruct a proper insertion ofthe shaft into the surgical device.